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FertiPro

Belgium·BE-MF-000000313

Last updated September 18, 2026

About

FertiPro is an ISO13485 certified company, that participates in the MDSAP program. FertiPro has product registrations in Europe, Canada, United States of America and in increasingly more countries worldwide. All of the diagnostic kits and ART media are CE marked either as in vitro diagnostics or as medical devices. Certificates of analysis for all products are available upon request.

From the manufacturer's own website. Source

What FertiPro makes

FertiPro manufactures diagnostic reagents and media for reproductive health, including sperm staining solutions (Spermac Stain A, B, and C), sperm analysis kits (SpermMar Test IgG and IgA), and culture media for assisted reproductive technology (FertiCult High Viscosity Oil, Sil-Select Plus). The company also produces reagents for sperm vitality and epithelial cell screening (VitalScreen, EpiScreen Plus) and devices for sperm preparation (Floater, Insert).

The portfolio includes devices classified as Class A, B, I, IIa, and III under EU regulations, with all relevant products listed in the EUDAMED database. FertiPro’s products are authorised as either in vitro diagnostics or medical devices, adhering to regulatory frameworks in Europe, Canada, and the United States. The company is headquartered in Belgium.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Belgium
Address: 32, Industriepark Noord, Beernem, Belgium
Website: www.fertipro.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +3250791805
PRRC Contact: —
EUDAMED SRN: BE-MF-000000313
FDA FEI Number: —
DUNS Number: —

Catalogue (66)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Spermac Stain B - 250 ml	SPS250B	EUDAMEDFDA UDI	Class A	Active
Floater	SPF_FLOATER_STR	EUDAMED	Class I	Active
Spermac Stain C - 250 ml	SPS250C	EUDAMEDFDA UDI	Class A	Active
FertiCult High Viscosity Oil	HVOIL500P	EUDAMEDFDA UDI	Class IIa	Active
VitalScreen Reagent 2	VITAL_2	EUDAMEDFDA UDI	Class A	Active
Spermac Stain A - 250 ml	SPS250A	EUDAMEDFDA UDI	Class A	Active
FertiCult High Viscosity Oil	HVOIL050	EUDAMEDFDA UDI	Class IIa	Active
Sil-Select Plus - 16 preparations	SIP016	EUDAMED	Class III	Active
SpermMar Test IgG antiserum	SPMG_A	EUDAMEDFDA UDI	Class B	Active
Insert	SPF_VIAL	EUDAMED	Class I	Active
SpermMar Test IgA Single kit	SPMA_S	EUDAMEDFDA UDI	Class B	Active
EpiScreen Plus Reagent 4	EPI_PLUS_4	EUDAMED	Class B	Active
FertiCult Mineral Oil	MINOIL050P	EUDAMEDFDA UDI	Class IIa	Active
LeucoScreen Plus Reagent 1	LEUCOP1	EUDAMEDFDA UDI	Class B	Active
Spermac Stain A - 50 ml	SPS050A	EUDAMEDFDA UDI	Class A	Active
FertiCult Mineral Oil	MINOIL050	EUDAMEDFDA UDI	Class IIa	Active
EpiScreen Plus Reagent 2	EPI_PLUS_2	EUDAMED	Class B	Active
EpiScreen Plus Reagent 5	EPI_PLUS_5	EUDAMED	Class B	Active
Sil-Select Plus with phenol red and gentamicin - 8 preparations	SIP008PRG	EUDAMED	Class III	Active
EpiScreen Plus Reagent 6	EPI_PLUS_6	EUDAMED	Class B	Active
Drdp	DRDP_0002	EUDAMED	Class A	Active
LeucoScreen Plus Reagent 4	LEUCOP4	EUDAMEDFDA UDI	Class B	Active
VitalScreen Reagent 1	VITAL_1	EUDAMEDFDA UDI	Class A	Active
SpermMar Test IgG Single kit	SPMG_S	EUDAMEDFDA UDI	Class B	Active
Sil-Select Plus - 8 preparations	SIP008	EUDAMED	Class III	Active
Spermac Stain C - 50 ml	SPS050C	EUDAMEDFDA UDI	Class A	Active
SpermMar Test IgG Latex bead solution	SPMG_L	EUDAMEDFDA UDI	Class B	Active
Fructose Test Reagent 1	FRUCTO_1	EUDAMED	Class B	Active
InActiv Blue	IB_TUB	EUDAMEDFDA UDI	Class A	Active
Spermac Stain - 4x50ml	SPS050	EUDAMEDFDA UDI	Class A	Active
SpermFreeze Box	SPF_Box	EUDAMED	Class I	Active
FertiCult High Viscosity Oil	HVOIL100	EUDAMEDFDA UDI	Class IIa	Active
Blue Collect	IB_CD01	EUDAMED	Class A	Active
LeucoScreen Plus	LEUCO_PLUS	EUDAMEDFDA UDI	Class B	Active
FertiCult High Viscosity Oil	HVOIL050P	EUDAMEDFDA UDI	Class IIa	Active
Fructose Test Reagent 2	FRUCTO_2	EUDAMED	Class B	Active
FertiCult High Viscosity Oil	HVOIL100P	EUDAMEDFDA UDI	Class IIa	Active
FertiCult Mineral Oil	MINOIL500P	EUDAMEDFDA UDI	Class IIa	Active
Sil-Select Plus - 2x 100ml	SIP100	EUDAMED	Class III	Active
Fructose Test Reagent 3	FRUCTO_3	EUDAMED	Class B	Active
LeucoScreen Plus Reagent 3	LEUCOP3	EUDAMEDFDA UDI	Class B	Active
FertiCult Mineral Oil	MINOIL100P	EUDAMEDFDA UDI	Class IIa	Active
HOS Test	HOST	EUDAMEDFDA UDI	Class B	Active
SpermMar Test IgG Negative Control	SPMG_N	EUDAMEDFDA UDI	Class B	Active
SpermMar Test IgG Complete kit	SPMG_C	EUDAMEDFDA UDI	Class B	Active
DRD Blood	DRDB_1	EUDAMED	Class A	Active
SpermMar Test IgA Complete kit	SPMA_C	EUDAMED	Class B	Active
Sil-Select Plus - 2x 20ml	SIP020	EUDAMED	Class III	Active
Sil-Select Plus - 2x 50ml	SIP050	EUDAMED	Class III	Active
EpiScreen Plus Reagent 3	EPI_PLUS_3	EUDAMED	Class B	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Fertipro NV US